AI-based System for Lung Tuberculosis Screening: Diagnostic Accuracy Evaluation

Tuberculosis, Pulmonary Clinical Trial

Official title:

AI-based System for Lung Tuberculosis Screening: Diagnostic Accuracy Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05889364
• Other study ID #: 2018-1
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Testing of AI solutions to assess diagnostic accuracy for tuberculosis detection.

Description:

Tuberculosis remains a key problem of modern medicine. New approaches for burden overcoming should be proposed. New screening strategies may include artificial intelligence (AI). An AI-based system for chest x-ray analysis and triage ("normal/tuberculosis suspected") have been developed and trained. A special data-set was prepared. There are 238 normal x-rays and 70 x-rays with lung tuberculosis in data-set. The data-set was randomly divided into 2 samples:

• sample N1 (n=140) with ratio "normal: tuberculosis" 50:50,

• sample N1 (n=150) with ratio "normal: tuberculosis" 95:5. Both samples will be analysed by AI-based system. Results will be quantified using diagnostic accuracy metrics: sensitivity and specificity, positive and negative predictor values, likelihood ratio, and area under the ROC (receiver operating characteristic) curve.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 308
• Est. completion date: December 30, 2023
• Est. primary completion date: March 15, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• no pathology in a lung on chest x-ray

• signs of lung tuberculosis on chest x-ray

Exclusion Criteria:

• any pathology in the lungs (except tuberculosis)

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Diagnostic Test:
• AI-based x-ray analysis and triage ("normal/tuberculosis suspected")
All included x-rays will be analysed by the AI-based system. Then results will be compared with opinions of 2 experienced radiologists (they make peer-review of all included images independently of each other).

Locations

Country	Name	City	State
Russian Federation	Research and Practical Center of Medical Radiology, Department of Health Care of Moscow	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy metric 1	Sensitivity	Day 1 upon receipt of data
Primary	Diagnostic accuracy metric 2	Specificity	Day 2 upon receipt of data
Primary	Diagnostic accuracy metric 3	Positive predictor values	Day 3 upon receipt of data
Primary	Diagnostic accuracy metric 4	Negative predictor values	Day 4 upon receipt of data
Primary	Diagnostic accuracy metric 5	Likelihood ratio	Day 5 upon receipt of data
Primary	Diagnostic accuracy metric 6	Area under the ROC curve	Day 6 upon receipt of data